Senior Product Quality Leader - Global QA

Allergan; North Chicago (IL); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Benefits package

401(k)

Job summary

AbbVie is seeking a senior Quality Assurance Operations Manager to lead on-time quality deliverables for pharmaceuticals, biologics, devices, and TPM collaborations. You will drive QA strategy and ensure regulatory conformance across AbbVie and third-party facilities.

The role requires extensive experience in QA, manufacturing, and regulatory interactions, with strong problem-solving and leadership abilities to manage complex tasks and cross-functional teams.

Qualifications

• Bachelor’s Degree in Life Science, Engineering, or other technical discipline.
• Total combined experience: minimum 8+ years.
• At least 3 years in Quality Assurance Operations Management; 5+ years in Operations, R&D, Regulatory or Consulting.
• Direct manufacturing plant experience in a pharmaceutical setting preferred.
• Experience with FDA and other regulatory agency interactions and inspections.

Responsibilities

• Maintains the primary quality lead with management oversight to achieve on-time quality deliverables.
• Participates in development of global Product Quality Assurance strategy for pharmaceutics, biologics, devices, and TPM facilities.
• Performs final quality release of manufactured product lots.
• Makes recommendations on quality and regulatory conformance and elevates high-risk events.
• Establishes relationships with Third Party Manufacturers and AbbVie plants to align quality expectations.

Skills

Quality assurance

Regulatory compliance

Problem solving

Leadership

Education

Bachelor's degree in Life Science/Engineering

Job description

AbbVie is seeking a senior Quality Assurance Operations Manager to lead on-time quality deliverables for pharmaceuticals, biologics, devices, and TPM collaborations. You will drive QA strategy and ensure regulatory conformance across AbbVie and third-party facilities.

The role requires extensive experience in QA, manufacturing, and regulatory interactions, with strong problem-solving and leadership abilities to manage complex tasks and cross-functional teams.